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Monkeypox
+2

New York City Observational Study of Mpox Immunity

Sponsored by NYU Langone Health

About this trial

Last updated 2 years ago

Study ID

22-01338

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 100 Years
All
All

Trial Timing

Started 3 years ago

What is this trial about?

The goal of this study is to assess the immune response, tolerance, and safety of the low-dose intradermal (forearm) mpox vaccine in people who are HIV+ compared to people who are HIV-, and compared to the standard-dose subcutaneous (upper arm) vaccine. The resulting data will fill knowledge gaps, inform public health practices, and address community concerns about the absence of data for low-dose intradermal mpox vaccinations in people living with HIV.

What are the participation requirements?

Yes

Inclusion Criteria

1. Must be able to understand and sign the Informed Consent Form (ICF)

2. ≥18 years of age a. Including breastfeeding and pregnant people

3. Must have one or the other of criteria a and b, or can have both:

1. Planning receipt of (in the next 30 days) or have received the mpox vaccine, and/or
2. people with recent mpox infection who are out of isolation (≥30 days after symptom onset)

4. Willingness and ability to participate in all study procedures

No

Exclusion Criteria

1. Known clinically significant anemia (i.e., Hb < 10 g/dL)

2. Contraindication to phlebotomy based on investigator judgement; e.g., anti-coagulation therapy with history of phlebotomy complications, or clinically significant thrombocytopenia

3. Any condition that, in the opinion of the Investigator, would make study participation unsafe for the individual or would interfere with the objectives of the study

Locations

Location

Status

Recruiting